NUROFENBABY "60 MG SUPPOSITORIES" 10 SUPPOSITORIES IN BLISTER AL"

Name
Nurofenbaby 60 mg suppositories
Ibuprofen


What is it and what is it for?
Nurofenbaby contains ibuprofen and belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). These medications work by controlling the response to pain and fever.

Nurofenbaby is indicated for the short-term symptomatic treatment of:
• fever;
• mild to moderate pain.

Nurofenbaby is particularly indicated when oral administration is not advisable, e.g. in case of vomiting.

Nurofenbaby is indicated for children from 6 kg (3 months) to 12.5 kg (2 years) of body weight.

Contact your doctor if you notice no improvement or if you notice worsening of symptoms after 24 hours in infants aged 3 to 5 months or after 3 days of treatment in children aged 6 months and older.


What you need to know before taking the medicine
Do not use Nurofenbaby:
• if you are allergic (hypersensitive) to ibuprofen or other similar pain relievers (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6);
• if you have suffered from shortness of breath, asthma, rhinorrhea (runny nose), swelling of the face and/or hands or hives after using ibuprofen, acetylsalicylic acid or other similar pain relievers (NSAIDs);
• if you have a history of gastrointestinal bleeding or perforation associated with previous NSAID treatment;
• if you have or have had two or more episodes of gastric/duodenal ulcer (peptic ulcer) or bleeding;
• if you have a cerebrovascular haemorrhage or other types of active bleeding;
• if you suffer from unexplained blood formation disorders;
• if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
• if you suffer from severe kidney, liver or heart failure;
• if you are in the last 3 months of pregnancy;
• in children weighing less than 6.0 kg (under 3 months of age).


Warnings and precautions
Talk to your doctor or pharmacist before using Nurofenbaby:

• if you have an infection – see section “Infections” below;
• in the presence of certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
• if you suffer from a hereditary disorder of blood formation (e.g. acute intermittent porphyria);
• if you suffer from blood clotting disorders;
• in the presence or case of previous gastrointestinal diseases (ulcerative colitis or Crohn's disease);
• if you have ever suffered from high blood pressure and/or heart failure;
• if you have reduced kidney function;
• if you suffer from liver problems;
• in the presence of disorders of the rectum or anus;
• in case of previous episodes of high blood pressure and/or heart failure;
• if you suffer or have suffered from asthma or allergic diseases, as you may experience shortness of breath;
• if you suffer from hay fever, nasal polyps, or chronic obstructive pulmonary disease, there is an increased risk of allergic reactions. Allergic reactions may manifest themselves in the form of asthma attacks (so-called "painkiller asthma"), Quincke's edema, or urticaria;
• if gastrointestinal bleeding, ulceration or perforation occurs due to this medicine.
These conditions are not necessarily preceded by warning symptoms, do not only affect patients with a previous history of serious gastrointestinal events, and can be fatal. If gastrointestinal bleeding or ulceration occurs in patients taking Nurofenbaby, treatment should be discontinued. Caution should be exercised in patients taking other drugs that could increase the risk of ulceration or bleeding, such as oral corticosteroids (such as prednisolone), anticoagulants (such as warfarin), selective serotonin reuptake inhibitors (medicines to treat depression), or antiplatelet agents (such as aspirin);
• if you are taking other NSAIDs (including selective COX-2 inhibitors such as celecoxib or etoricoxib);
• in the presence of chickenpox it is advisable to avoid the use of Nurofenbaby;
• in case of prolonged administration of Nurofenbaby, regular monitoring of liver values, kidney function and blood count is required;
• undesirable effects may be minimised by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms;
• elderly patients have an increased risk of side effects;
• In general, the habitual use of analgesics can lead to serious and permanent kidney problems. This risk may increase with physical exertion associated with salt loss and dehydration. Therefore, it should be avoided;
• Prolonged use of any type of painkiller for headaches can worsen symptoms. If this occurs or is suspected, consult your doctor and discontinue treatment. The diagnosis of overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of painkillers;
• taking it in combination with other NSAIDs, including selective cyclooxygenase-2 inhibitors, may increase the risk of adverse reactions (see section "Other medicines and Nurofenbaby") and should be avoided;
• Medicines such as Nurofenbaby may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment, which is a maximum of 24 hours for infants aged 3 to 5 months and a maximum of 3 days for children aged 6 months and older;
• if you have heart problems or a history of stroke or think you may be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or if you are a smoker) you should discuss your treatment with your doctor or pharmacist.
Signs of an allergic reaction to ibuprofen have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop taking Nurofenbaby immediately and contact your doctor or emergency services immediately if you notice any of these signs.
• there is a risk of kidney damage in dehydrated children;
• special medical supervision is required immediately after major surgery.

Infections
Nurofenbaby may mask the symptoms of infections, such as fever and pain. Therefore, Nurofenbaby may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms persist or worsen, contact your doctor immediately.

Skin reactions
Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment.
Stop using Nurofenbaby and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.


Possible side effects
Like all medicines, Nurofenbaby can cause side effects, although not everybody gets them.

Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.

You may experience one of the known side effects of NSAIDs (see below). If this happens, or if you are concerned, stop taking this medicine and tell your doctor as soon as possible. Elderly people taking this medicine are at greater risk of developing problems associated with side effects.

Stop using this medicine and see your doctor immediately if you develop:
• signs of intestinal bleeding such as: severe abdominal pain, dark stools, vomiting blood or dark particles resembling coffee grounds;
• signs of very rare but serious allergic reactions such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, or a drop in blood pressure leading to shock. These symptoms may occur even when you first use this medicine;
• flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and ulcers of the mouth, throat, nose, genitals, and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis] [Very rare - may affect up to 1 in 10,000 people];
• widespread skin rash, high body temperature, swollen lymph nodes and increased eosinophils (a type of white blood cell) (DRESS syndrome) [Not known - frequency cannot be estimated from the available data];
• widespread, red, scaly rash with bumps under the skin and blisters, mainly located in the skin folds, on the trunk and upper limbs, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis) [Not known - frequency cannot be estimated from the available data].

Consult your doctor if you experience any of the other possible side effects.
Common (may affect up to 1 in 10 people):
• Gastric disorders, such as heartburn, stomach pain and nausea, indigestion, diarrhoea, vomiting, flatulence and constipation and slight bleeding in the stomach and/or intestine which in exceptional cases may cause anaemia.

Uncommon (may affect up to 1 in 100 people):
• hypersensitivity reactions with urticaria and itching;
• gastrointestinal ulcers, perforation or bleeding, inflammation of the mucosa of the mouth with ulceration (ulcerative stomatitis), worsening of existing intestinal disorders (colitis or Crohn's disease), gastritis, localized rectal irritation;
• central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness;
• vision disorders;
• various skin rashes.

Rare (may affect up to 1 in 1,000 people):
• tinnitus (ringing in the ears);
• increased concentrations of urea in the blood, pain in the flanks and/or abdomen, blood in the urine and fever which may be a sign of kidney damage (papillary necrosis);
• decrease in hemoglobin levels.

Very rare (may affect up to 1 in 10,000 people):
• inflammation of the esophagus, pancreatitis, formation of diaphragmatic-like intestinal structures;
• heart failure, heart attack and swelling of the face and hands (edema);
• less urine than normal and swelling (especially in patients with high blood pressure or reduced kidney function); swelling (edema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis), which can lead to acute kidney failure. If any of the above symptoms occur or if you feel generally unwell, stop taking Nurofenbaby and consult your doctor immediately, as these may be the first signs of kidney damage or kidney failure;
• psychotic reactions, depression;
• high blood pressure, vasculitis;
• palpitations;
• liver dysfunction, liver damage (the first signs may be skin discoloration), especially during long periods of treatment, liver failure, acute inflammation of the liver (hepatitis);
• Problems with blood cell production – the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, and unexplained bruising. In these cases, you should stop treatment immediately and consult your doctor immediately. Avoid over-the-counter treatment with painkillers or fever-reducing medications (antipyretics).
• serious skin infections and soft tissue complications during chickenpox infection;
• worsening of infection-related inflammation (e.g. necrotizing fasciitis) has been described in association with the use of some analgesics (NSAIDs). If signs of an infection appear or worsen, you should contact your doctor immediately to assess whether anti-infective/antibiotic therapy is necessary;
• Symptoms of aseptic meningitis, including numbness in the neck, headache, nausea, vomiting, fever, or disorientation, have been observed while using ibuprofen. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more likely to develop these symptoms. Contact a doctor immediately if these symptoms occur.
• Hair loss (alopecia).

Not known (frequency cannot be estimated from the available data):
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• respiratory tract reactivity including asthma, bronchospasm or dyspnea;
• the skin becomes sensitive to light.

Medicines such as Nurofenbaby may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.